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Surgical Treatment of Low Energy Pelvic Fractures in the Elderly (PelvicRetro)

Primary Purpose

Fracture

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Outcome after surgery
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Fracture focused on measuring Pelvic, Treatment Outcome

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elderly patients (age ≥55y ears) of any ethnic / sociodemographic background
  • Pelvic ring fracture after low energy trauma affecting the posterior ring or both (posterior and anterior ring)
  • Surgical stabilisation of the pelvic ring at Basel University Hospital between May 2010 and December 2014
  • Ambulatory before surgery
  • Informed consent for study participation by the patient or legal representatives

Exclusion Criteria:

  • Refusal of consent by the patient or legal representatives to participate in the study
  • Fractures within the last 3 months before follow-up
  • Suspicion of a pathological fracture in the context of known or unknown malignancy
  • Symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc.
  • Pre-trauma mobility status that precludes achieving a post-trauma mobility status enabling the patient to perform the timed up and go test (e.g. patient in a wheel chair)

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Follow-up

Arm Description

Patients have not received a structured follow up examination or evaluation of outcome after surgery. Therefore this study aims at conducting a follow up examination regarding functional outcome, pain and radiologic healing in these patients.

Outcomes

Primary Outcome Measures

TUG-Test through study completion, an average of 1 year
TUG test - according test description

Secondary Outcome Measures

activity of daily living (ADL) through study completion, an average of 1 year
ADL test - according test description
Pain test through study completion, an average of 1 year
Maximal pain (VAS 1-10) experienced during TUG-test and at rest at the day of follow up
Living Situation through study completion, an average of 1 year
Living situation before and after the injury (at home/institutional placement) according test procedure
1-year mortality

Full Information

First Posted
October 8, 2015
Last Updated
September 28, 2016
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02591043
Brief Title
Surgical Treatment of Low Energy Pelvic Fractures in the Elderly
Acronym
PelvicRetro
Official Title
Surgical Treatment of Low Energy Pelvic Ring Fractures in the Elderly: Cross-sectional Single-centre Study From Basel, Switzerland
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Since May 2010 the Department of Trauma, Basel University Hospital has performed surgical stabilisation of the posterior pelvic ring on 55 patients. These patients have not received a structured follow up examination or evaluation of outcome after surgery.
Detailed Description
Functional outcome of elderly patients with surgical treatment of low energy pelvic ring fractures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture
Keywords
Pelvic, Treatment Outcome

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Follow-up
Arm Type
Other
Arm Description
Patients have not received a structured follow up examination or evaluation of outcome after surgery. Therefore this study aims at conducting a follow up examination regarding functional outcome, pain and radiologic healing in these patients.
Intervention Type
Procedure
Intervention Name(s)
Outcome after surgery
Intervention Description
Functional outcome after surgical treatment of pelvic ring fractures Measurements: TUG-test score, ADLs index, maximal pain (VAS 1-10) at rest and experienced during TUG-test. One-year mortality, signs of healing, dislocation or other complications on anterior-posterior radiographs of the pelvis, living situation before and after the injury (at home/institutional placement)
Primary Outcome Measure Information:
Title
TUG-Test through study completion, an average of 1 year
Description
TUG test - according test description
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
activity of daily living (ADL) through study completion, an average of 1 year
Description
ADL test - according test description
Time Frame
through study completion, an average of 1 year
Title
Pain test through study completion, an average of 1 year
Description
Maximal pain (VAS 1-10) experienced during TUG-test and at rest at the day of follow up
Time Frame
through study completion, an average of 1 year
Title
Living Situation through study completion, an average of 1 year
Description
Living situation before and after the injury (at home/institutional placement) according test procedure
Time Frame
through study completion, an average of 1 year
Title
1-year mortality
Time Frame
one year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elderly patients (age ≥55y ears) of any ethnic / sociodemographic background Pelvic ring fracture after low energy trauma affecting the posterior ring or both (posterior and anterior ring) Surgical stabilisation of the pelvic ring at Basel University Hospital between May 2010 and December 2014 Ambulatory before surgery Informed consent for study participation by the patient or legal representatives Exclusion Criteria: Refusal of consent by the patient or legal representatives to participate in the study Fractures within the last 3 months before follow-up Suspicion of a pathological fracture in the context of known or unknown malignancy Symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc. Pre-trauma mobility status that precludes achieving a post-trauma mobility status enabling the patient to perform the timed up and go test (e.g. patient in a wheel chair)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Hasler, Dr
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23871193
Citation
Rommens PM, Hofmann A. Comprehensive classification of fragility fractures of the pelvic ring: Recommendations for surgical treatment. Injury. 2013 Dec;44(12):1733-44. doi: 10.1016/j.injury.2013.06.023. Epub 2013 Jul 18.
Results Reference
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Surgical Treatment of Low Energy Pelvic Fractures in the Elderly

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